Skip to main content
OpenTrials
Completed

NCT Number: NCT00493415

The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis

The purpose of this study is to evaluate the effect of nitro-glycerine on the microcirculation (smallest vessel type) in patients with severe sepsis and septic shock.

Nitro-glycerine is a well known medicine in cardiology and is used to improve circulation. In this ICU the investigators use nitro-glycerine to improve the organ perfusion; but it's no common therapy in the rest of the world. The investigators now compare nitro-glycerine and placebo by looking to the sublingual microcirculation by a small camera (SDF imaging).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Centre Leeuwarden - Intensive Care Unit

Leeuwarden, 8901 BR, Netherlands

About this study

This study starts at admission of the patient on the ICU. In the next 24 hours the patient receives nitro-glycerine or placebo (randomised). At time = 0, ½, 2, 12 and 24 hour we evaluate the microcirculation by SDF imaging and monitoring of hemodynamic parameters.

Informed consent is obtained of the relatives.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Severe sepsis
  • Proven infection
  • Informed consent

Exclusion criteria

  • Age < 18 years
  • Pregnancy
  • Use of nitroglycerine within 24 hours prior to ICU admittance
  • Necessity to use nitroglycerine iv for instable angina

Treatment and study plan

nitroglycerin iv

Drug

loading dose of 4mg/h iv in the first 30 minutes, 2 mg/h iv in the next 23 hours and 30 minutes

Other names: nitropohl

placebo = nacl 0.9%

Drug

4 ml/h iv in the first 30 minutes, 2 ml /h iv in the next 23 hours and 30 minutes

Other names: isotonic saline

Primary outcomes

  1. increase of MFI by nitro-glycerine

    Time frame: 2 years

Secondary outcomes

  1. decrease of length of stay decrease of SOFA decrease of morbidity/mortality

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Frisius Medisch Centrum

Other

Registry information

Official study title

The Evaluation of the Effect of Nitroglycerine Versus Placebo on the Microcirculation by Means of SDF Imaging in Septic Patients on the ICU

Acronym: NISMIS

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 28, 2007
Registry last updated
Jul 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.